Diphtheria, Hepatitis B, Pertussis, Polio
Conditions
Keywords
Hepatitis B, Polio, Diphtheria, Pertussis, H.influenzae type b
Brief summary
This is a follow-up of Study A3L10 (NCT00315055) Immunogenicity * To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP\ T or PENTAXIM™ and ENGERIX B®. * To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP\ T. Safety \- To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP\ T.
Interventions
BIOLOGICALDTaP-IPV-HB-PRP~T vaccine
0.5 mL, intramuscular (IM)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Toddler previously included in Study A3L10 who completed the three-dose primary series vaccination of either DTaP-IPV-HB-PRP\ T or PENTAXIM™ and ENGERIX B® at 2, 3 and 4 months of age. * Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive). * Informed Consent Form signed by the parent(s) or other legal representative(s) and an institution official other than an Investigator. * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Participation in another clinical trial in the 4 weeks preceding the booster vaccination. * Planned participation in another clinical trial during the present trial period. * Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy. * Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances. * Chronic illness at a stage that could interfere with trial conduct or completion. * Blood or blood-derived products received in the last 3 months. * Any vaccination in the 4 weeks preceding the booster vaccination. * Any vaccination planned until second Visit. * History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically). * Previous booster vaccination against pertussis, tetanus, diphtheria, polio or Haemophilus influenzae type b, and hepatitis B infection(s). * Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination. * Any vaccine-related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L10 (NCT00315055). * Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion. * Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; temperature \> 40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for \> 3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Day 0 before and Day 30 Post-booster vaccination | Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA. |
| Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Day 0 before and Day 30 post-booster vaccination | Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). |
| Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Day 0 up to Day 7 post-booster vaccination | Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying \> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Participants were enrolled from 14 December 2007 to 07 January 2008 at 1 clinical center in Turkey.
Pre-assignment details
A total of 254 participants who met all inclusion, but no exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| DTaP-IPV-HepB-PRP~T All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\
T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\
T at 15 to 18 months of age in the present study. | 130 |
| Pentaxim™ + Engerix B™ All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\
T at 15 to 18 months of age in the present study. | 124 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 10 |
Baseline characteristics
| Characteristic | Pentaxim™ + Engerix B™ | DTaP-IPV-HepB-PRP~T | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 124 Participants | 130 Participants | 254 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 17.6 Months STANDARD_DEVIATION 0.279 | 17.6 Months STANDARD_DEVIATION 0.198 | 17.6 Months STANDARD_DEVIATION 0.241 |
| Region of Enrollment Turkey | 124 Participants | 130 Participants | 254 Participants |
| Sex: Female, Male Female | 54 Participants | 56 Participants | 110 Participants |
| Sex: Female, Male Male | 70 Participants | 74 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 56 / 130 | 67 / 124 |
| serious Total, serious adverse events | 4 / 130 | 2 / 124 |
Outcome results
Primary
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA).
Time frame: Day 0 before and Day 30 post-booster vaccination
Population: GMTs were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per Protocol Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Hep B Pre-booster (N = 109, 103) | 44.2 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Hep B Post-booster (N = 111, 103) | 1379 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-PRP Pre-booster (N = 113, 102) | 0.724 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-PRP Post-booster (N = 114, 103) | 72.5 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Diphtheria Pre-booster (N = 104, 94) | 0.028 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Diphtheria Post-booster (N = 112, 98) | 5.09 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Tetanus Pre-booster (N = 97, 90) | 0.244 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Tetanus Post-booster (N = 109, 96) | 8.98 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Polio 1 Pre-booster (N= 88, 86) | 110 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Polio 1 Post-booster (N = 105, 87) | 5477 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Polio 2 Pre-booster (N = 84, 87) | 114 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Polio 2 Post-booster (N = 101, 83) | 6099 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Polio 3 Pre-booster (N = 88, 86) | 47.1 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Polio 3 Post-booster (N = 102, 84) | 5542 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-PT Pre-booster (N = 86, 87) | 6.08 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-PT Post-booster (N = 113, 95) | 160 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-FHA Pre-booster (N = 74, 81) | 12.5 Titers |
| DTaP-IPV-HepB-PRP~T | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-FHA Post-booster (N = 111, 97) | 222 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Polio 3 Post-booster (N = 102, 84) | 10152 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Hep B Pre-booster (N = 109, 103) | 223 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Polio 1 Post-booster (N = 105, 87) | 9050 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Hep B Post-booster (N = 111, 103) | 26189 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-FHA Post-booster (N = 111, 97) | 234 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-PRP Pre-booster (N = 113, 102) | 0.612 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Polio 2 Pre-booster (N = 84, 87) | 131 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-PRP Post-booster (N = 114, 103) | 86.9 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-PT Pre-booster (N = 86, 87) | 7.49 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Diphtheria Pre-booster (N = 104, 94) | 0.032 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Polio 2 Post-booster (N = 101, 83) | 9170 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Diphtheria Post-booster (N = 112, 98) | 10.2 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-FHA Pre-booster (N = 74, 81) | 8.18 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Tetanus Pre-booster (N = 97, 90) | 0.194 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Polio 3 Pre-booster (N = 88, 86) | 101 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Tetanus Post-booster (N = 109, 96) | 13.1 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-PT Post-booster (N = 113, 95) | 237 Titers |
| Pentaxim™ + Engerix B™ | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti-Polio 1 Pre-booster (N= 88, 86) | 114 Titers |
Primary
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying \> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable.
Time frame: Day 0 up to Day 7 post-booster vaccination
Population: Solicited reactions were assessed in all participants who received a booster dose of DTaP-IPV-Hep B-PRP\~T according to the primary series received (Safety Analysis Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Swelling | 2 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Vomiting | 2 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Erythema | 3 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Crying | 29 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Extensive Swelling of Vaccinated Limb | 0 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Crying | 3 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Erythema | 35 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Somnolence | 24 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Pyrexia | 29 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Somnolence | 2 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Swelling | 26 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anorexia | 40 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Pyrexia | 1 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Anorexia | 9 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Pain | 4 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Irritability | 51 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Vomiting | 13 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Irritability | 5 Participants |
| DTaP-IPV-HepB-PRP~T | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Pain | 56 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Irritability | 7 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Pain | 67 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Pain | 2 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Erythema | 50 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Erythema | 4 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Swelling | 36 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Swelling | 3 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Extensive Swelling of Vaccinated Limb | 0 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Pyrexia | 36 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Pyrexia | 0 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Vomiting | 11 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Vomiting | 2 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Crying | 35 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Crying | 4 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Somnolence | 25 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Somnolence | 3 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anorexia | 43 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Grade 3 Anorexia | 8 Participants |
| Pentaxim™ + Engerix B™ | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Irritability | 61 Participants |
Primary
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™
Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA.
Time frame: Day 0 before and Day 30 Post-booster vaccination
Population: Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Hep B Pre-booster (N = 109, 103) | 81 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Hep B Post-booster (N = 111, 103) | 97 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-PRP Pre-booster (N = 113,102) | 85 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-PRP Post-booster (N = 114, 103) | 100 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Diphtheria Pre-booster (N = 104, 94) | 90 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Diphtheria Post-booster (N = 112, 98) | 100 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Tetanus Pre-booster (N = 97, 90) | 100 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Tetanus Post-booster (N = 109, 96) | 100 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Polio 1 Pre-booster (N = 88, 86) | 99 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Polio 1 Post-booster (N = 105, 87) | 100 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Polio 2 Pre-booster (N = 84, 87) | 100 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Polio 2 Post-booster (N = 101, 83) | 100 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Polio 3 Pre-booster (N = 88,86) | 85 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Polio 3 Post-booster (N = 102, 84) | 100 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-PT Post-booster (N = 86, 79) | 97 Percentage of Participants |
| DTaP-IPV-HepB-PRP~T | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-FHA Post-booster (N = 73,77) | 92 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-FHA Post-booster (N = 73,77) | 97 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Hep B Pre-booster (N = 109, 103) | 99 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Polio 1 Pre-booster (N = 88, 86) | 99 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Hep B Post-booster (N = 111, 103) | 100 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Polio 3 Pre-booster (N = 88,86) | 97 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-PRP Pre-booster (N = 113,102) | 83 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Polio 1 Post-booster (N = 105, 87) | 100 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-PRP Post-booster (N = 114, 103) | 100 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-PT Post-booster (N = 86, 79) | 96 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Diphtheria Pre-booster (N = 104, 94) | 88 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Polio 2 Pre-booster (N = 84, 87) | 98 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Diphtheria Post-booster (N = 112, 98) | 100 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Polio 3 Post-booster (N = 102, 84) | 100 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Tetanus Pre-booster (N = 97, 90) | 100 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Polio 2 Post-booster (N = 101, 83) | 100 Percentage of Participants |
| Pentaxim™ + Engerix B™ | Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Anti-Tetanus Post-booster (N = 109, 96) | 100 Percentage of Participants |